Surgical instrument having a feedback system

ABSTRACT

A surgical instrument. The surgical instrument comprises a plurality of sensors, and a status module releasably connected to the surgical instrument. The status module comprises a plurality of contacts, a circuit, and a plurality of indicators. Each individual contact is in electrical communication with a different sensor. The circuit is in electrical communication with at least one of the contacts. At least one of the indicators is in electrical communication with the circuit.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 15/077,375, entitledSURGICAL INSTRUMENT HAVING A FEEDBACK SYSTEM, filed Mar. 22, 2016, nowU.S. Patent Application Publication No. 2016/0199059, which is acontinuation application claiming priority under 35 U.S.C. § 120 to U.S.patent application Ser. No. 14/224,878, entitled SURGICAL INSTRUMENTHAVING A FEEDBACK SYSTEM, filed Mar. 25, 2014, which issued on Aug. 29,2017 as U.S. Pat. No. 9,743,928, which is a continuation applicationclaiming priority under 35 U.S.C. § 120 to U.S. patent application Ser.No. 11/343,545, entitled SURGICAL INSTRUMENT HAVING A FEEDBACK SYSTEM,filed Jan. 31, 2006, which issued on Apr. 29, 2014 as U.S. Pat. No.8,708,213, the entire disclosures of which are hereby incorporated byreference herein.

This application is related to the following U.S. patents and patentapplications, which are incorporated herein by reference:

(1) U.S. patent application Ser. No. 11/343,498, now U.S. Pat. No.7,766,210, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH USER FEEDBACK SYSTEM;

(2) U.S. patent application Ser. No. 11/343,573, now U.S. Pat. No.7,416,101, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH LOADING FORCE FEEDBACK;

(3) U.S. patent application Ser. No. 11/344,035, now U.S. Pat. No.7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH TACTILE POSITION FEEDBACK;

(4) U.S. patent application Ser. No. 11/343,447, now U.S. Pat. No.7,770,775, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH ADAPTIVE USER FEEDBACK;

(5) U.S. patent application Ser. No. 11/343,562, now U.S. Pat. No.7,568,603, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH ARTICULATABLE END EFFECTOR;

(6) U.S. patent application Ser. No. 11/344,024, now U.S. Pat. No.8,186,555, entitled MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH MECHANICAL CLOSURE SYSTEM;

(7) U.S. patent application Ser. No. 11/343,321, now U.S. PatentApplication Publication No. 2007/0175955, entitled SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM;

(8) U.S. patent application Ser. No. 11/343,563, now U.S. PatentApplication Publication No. 2007/0175951, entitled GEARING SELECTOR FORA POWERED SURGICAL CUTTING AND FASTENING STAPLING INSTRUMENT;

(9) U.S. patent application Ser. No. 11/343,803, now U.S. Pat. No.7,845,537, entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES;

(10) U.S. patent application Ser. No. 11/344,020, now U.S. Pat. No.7,464,846, entitled SURGICAL INSTRUMENT HAVING A REMOVABLE BATTERY;

(11) U.S. patent application Ser. No. 11/343,439, now U.S. Pat. No.7,644,848, entitled ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENTINCLUDING SAME;

(12) U.S. patent application Ser. No. 11/343,547, now U.S. Pat. No.7,753,904, entitled ENDOSCOPIC SURGICAL INSTRUMENT WITH A HANDLE THATCAN ARTICULATE WITH RESPECT TO THE SHAFT;

(13) U.S. patent application Ser. No. 11/344,021, now U.S. Pat. No.7,464,849, entitled ELECTRO-MECHANICAL SURGICAL CUTTING AND FASTENINGINSTRUMENT HAVING A ROTARY FIRING AND CLOSURE SYSTEM WITH PARALLELCLOSURE AND ANVIL ALIGNMENT COMPONENTS; and

(14) U.S. patent application Ser. No. 11/343,546, now U.S. PatentApplication Publication No. 2007/0175950, entitled DISPOSABLE STAPLECARTRIDGE HAVING AN ANVIL WITH TISSUE LOCATOR FOR USE WITH A SURGICALCUTTING AND FASTENING INSTRUMENT AND MODULAR END EFFECTOR SYSTEMTHEREFOR.

BACKGROUND

This application discloses an invention that is related, generally andin various embodiments, to visual and audible feedback systems formotor-driven surgical instruments.

Endoscopic surgical instruments are often preferred over traditionalopen surgical devices since a smaller incision tends to reduce thepost-operative recovery time and complications. Consequently,significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Known surgical staplers include an end effector that simultaneouslymakes a longitudinal incision in tissue and applies lines of staples onopposing sides of the incision. The end effector includes a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges which, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Pat. No. 5,465,895, which discloses an endocutter withdistinct closing and firing actions. A clinician using this device isable to close the jaw members upon tissue to position the tissue priorto firing. Once the clinician has determined that the jaw members areproperly gripping tissue, the clinician can then fire the surgicalstapler with either single or multiple firing strokes, thereby severingand stapling the tissue. The simultaneous severing and stapling avoidscomplications that may arise when performing such actions sequentiallywith different surgical tools that respectively only sever or staple.

One specific advantage of being able to close upon tissue before firingis that the clinician is able to verify via an endoscope that thedesired location for the cut has been achieved, including a sufficientamount of tissue has been captured between opposing jaws. Otherwise,opposing jaws may be drawn too close together, especially pinching attheir distal ends, and thus not effectively forming closed staples inthe severed tissue. At the other extreme, an excessive amount of clampedtissue may cause binding and an incomplete firing.

Endoscopic staplers/cutters continue to increase in complexity andfunction with each generation. One of the main reasons for this is thequest for lower force-to-fire (FTF) to a level that all or a greatmajority of surgeons can handle. One known solution to lower FTF it useCO₂ or electrical motors. These devices have not fared much better thantraditional hand-powered devices, but for a different reason. Surgeonstypically prefer to experience proportionate force distribution to thatbeing experienced by the end-effector in the forming the staple toassure them that the cutting/stapling cycle is complete, with the upperlimit within the capabilities of most surgeons (usually around 15-30lbs). They also typically want to maintain control of deploying thestaple and being able to stop at any time if the forces felt in thehandle of the device feel too great or for some other clinical reason.These user-feedback effects are not suitably realizable in presentmotor-driven endocutters. As a result, there is a general lack ofacceptance by physicians of motor-drive endocutters where thecutting/stapling operation is actuated by merely pressing a button.

With current surgical instruments, the status of the instrument isgenerally not provided to a user of the surgical instrument during aprocedure. For example, with current mechanical endocutters, thepresence of the staple cartridge, the position of the knife, the timeelapsed since clamping, the magnitude of the firing force, etc. aregenerally not provided to the user. Without visual and/or audiblefeedback, each user must rely on his or her own “feel” to determine thestatus of the surgical instrument, thereby creating inefficiencies,inconsistencies, and potential damage to the surgical instrument.

SUMMARY

In one general respect, this application discloses a status module foruse with a surgical instrument comprising a plurality of sensors.According to various embodiments, the status module comprises a housing,a plurality of contacts, a circuit, and a plurality of indicators. Thehousing is structured and arranged to releasably connect to the surgicalinstrument. Each individual contact is structured and arranged to be inelectrical communication with a different sensor when the housing isconnected to the surgical instrument. The circuit is in electricalcommunication with at least one of the contacts. At least one of theindicators is in electrical communication with the circuit.

In another general respect, this application discloses a surgicalinstrument. According to various embodiments, the surgical instrumentcomprises a plurality of sensors, and a status module releasablyconnected to the surgical instrument. The status module comprises aplurality of contacts, a circuit, and a plurality of indicators. Eachindividual contact is in electrical communication with a differentsensor. The circuit is in electrical communication with at least one ofthe contacts. At least one of the indicators is in electricalcommunication with the circuit.

DRAWINGS

Various embodiments of the disclosed invention are described herein byway of example in conjunction with the following figures.

FIGS. 1 and 2 are perspective views of a surgical cutting and fasteninginstrument according to various embodiments;

FIGS. 3-5 are exploded views of an end effector and shaft of theinstrument according to various embodiments;

FIG. 6 is a side view of the end effector according to variousembodiments;

FIG. 7 is an exploded view of the handle of the instrument according tovarious embodiments;

FIGS. 8 and 9 are partial perspective views of the handle according tovarious embodiments;

FIG. 10 is a side view of the handle according to various embodiments;

FIG. 11 is a schematic diagram of a circuit used in the instrumentaccording to various embodiments;

FIGS. 12-13 are side views of the handle according to variousembodiments;

FIGS. 14-22 illustrate different mechanisms for locking the closuretrigger according to various embodiments;

FIGS. 23A-B show a universal joint (“u-joint”) that may be employed atthe articulation point of the instrument according to variousembodiments;

FIGS. 24A-B shows a torsion cable that may be employed at thearticulation point of the instrument according to various embodiments;

FIGS. 25-31 illustrate a surgical cutting and fastening instrument withpower assist according to various embodiments;

FIGS. 32-36 illustrate a surgical cutting and fastening instrument withpower assist according to various embodiments;

FIGS. 37-40 illustrate a surgical cutting and fastening instrument withtactile feedback according to various embodiments;

FIGS. 41-42 illustrate various embodiments of a proportional sensor;

FIG. 43 illustrates various embodiments of a surgical instrument;

FIG. 44 is a schematic diagram of the surgical instrument of FIG. 43;and

FIGS. 45-47 illustrate various embodiments of a portion of the surgicalinstrument of FIG. 43.

DETAILED DESCRIPTION

It is to be understood that at least some of the figures anddescriptions of the disclosed invention have been simplified toillustrate elements that are relevant for a clear understanding of thedisclosed invention, while eliminating, for purposes of clarity, otherelements. Those of ordinary skill in the art will recognize, however,that these and other elements may be desirable. However, because suchelements are well known in the art, and because they do not facilitate abetter understanding of the disclosed invention, a discussion of suchelements is not provided herein.

FIGS. 1 and 2 depict a surgical cutting and fastening instrument 10according to various embodiments of the present invention. Theillustrated embodiment is an endoscopic instrument and, in general, theembodiments of the instrument 10 described herein are endoscopicsurgical cutting and fastening instruments. It should be noted, however,that according to other embodiments of the present invention, theinstrument may be a non-endoscopic surgical cutting and fasteninginstrument, such as a laparoscopic instrument.

The surgical instrument 10 depicted in FIGS. 1 and 2 comprises a handle6, a shaft 8, and an articulating end effector 12 pivotally connected tothe shaft 8 at an articulation pivot 14. An articulation control 16 maybe provided adjacent to the handle 6 to effect rotation of the endeffector 12 about the articulation pivot 14. In the illustratedembodiment, the end effector 12 is configured to act as an endocutterfor clamping, severing and stapling tissue, although, in otherembodiments, different types of end effectors may be used, such as endeffectors for other types of surgical devices, such as graspers,cutters, staplers, clip appliers, access devices, drug/gene therapydevices, ultrasound, RF or laser devices, etc.

The handle 6 of the instrument 10 may include a closure trigger 18 and afiring trigger 20 for actuating the end effector 12. It will beappreciated that instruments having end effectors directed to differentsurgical tasks may have different numbers or types of triggers or othersuitable controls for operating the end effector 12. The end effector 12is shown separated from the handle 6 by a preferably elongate shaft 8.In one embodiment, a clinician or operator of the instrument 10 mayarticulate the end effector 12 relative to the shaft 8 by utilizing thearticulation control 16, as described in more detail in U.S. patentapplication Ser. No. 11/329,020, filed Jan. 10, 2006, entitled SURGICALINSTRUMENT HAVING AN ARTICULATING END EFFECTOR, now U.S. Pat. No.7,670,334, which is incorporated herein by reference.

The end effector 12 includes in this example, among other things, astaple channel 22 and a pivotally translatable clamping member, such asan anvil 24, which are maintained at a spacing that assures effectivestapling and severing of tissue clamped in the end effector 12. Thehandle 6 includes a pistol grip 26 towards which a closure trigger 18 ispivotally drawn by the clinician to cause clamping or closing of theanvil 24 toward the staple channel 22 of the end effector 12 to therebyclamp tissue positioned between the anvil 24 and channel 22. The firingtrigger 20 is farther outboard of the closure trigger 18. Once theclosure trigger 18 is locked in the closure position as furtherdescribed below, the firing trigger 20 may rotate slightly toward thepistol grip 26 so that it can be reached by the operator using one hand.Then the operator may pivotally draw the firing trigger 20 toward thepistol grip 26 to cause the stapling and severing of clamped tissue inthe end effector 12. In other embodiments, different types of clampingmembers besides the anvil 24 could be used, such as, for example, anopposing jaw, etc.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the handle 6 of aninstrument 10. Thus, the end effector 12 is distal with respect to themore proximal handle 6. It will be further appreciated that, forconvenience and clarity, spatial terms such as “vertical” and“horizontal” are used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and absolute.

The closure trigger 18 may be actuated first. Once the clinician issatisfied with the positioning of the end effector 12, the clinician maydraw back the closure trigger 18 to its fully closed, locked positionproximate to the pistol grip 26. The firing trigger 20 may then beactuated. The firing trigger 20 returns to the open position (shown inFIGS. 1 and 2) when the clinician removes pressure, as described morefully below. A release button 160 on the handle 6, and in this example,on the pistol grip 26 of the handle 6, when depressed may release thelocked closure trigger 18.

FIG. 3 is an exploded view of the end effector 12 according to variousembodiments. As shown in the illustrated embodiment, the end effector 12may include, in addition to the previously-mentioned channel 22 andanvil 24, a cutting instrument 32, a sled 33, a staple cartridge 34 thatis removably seated in the channel 22, and a helical screw shaft 36. Thecutting instrument 32 may be, for example, a knife. The anvil 24 may bepivotably opened and closed at a pivot point 25 connected to theproximate end of the channel 22. The anvil 24 may also include a tab 27at its proximate end that is inserted into a component of the mechanicalclosure system (described further below) to open and close the anvil 24.When the closure trigger 18 is actuated, that is, drawn in by a user ofthe instrument 10, the anvil 24 may pivot about the pivot point 25 intothe clamped or closed position. If clamping of the end effector 12 issatisfactory, the operator may actuate the firing trigger 20, which, asexplained in more detail below, causes the knife 32 and sled 33 totravel longitudinally along the channel 22, thereby cutting tissueclamped within the end effector 12. The movement of the sled 33 alongthe channel 22 causes the staples of the staple cartridge 34 to bedriven through the severed tissue and against the closed anvil 24, whichturns the staples to fasten the severed tissue. U.S. Pat. No. 6,978,921,entitled SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRINGMECHANISM, which is incorporated herein by reference, provides moredetails about such two-stroke cutting and fastening instruments.According to various embodiments, the sled 33 may be an integral part ofthe cartridge 34, such that when the knife 32 retracts following thecutting operation, the sled 33 does not retract.

It should be noted that although the embodiments of the instrument 10described herein employ an end effector 12 that staples the severedtissue, in other embodiments different techniques for fastening orsealing the severed tissue may be used. For example, end effectors thatuse RF energy or adhesives to fasten the severed tissue may also beused. U.S. Pat. No. 5,810,811, entitled ELECTROSURGICAL HEMOSTATICDEVICE, which is incorporated herein by reference, discloses a cuttinginstrument that uses RF energy to fasten the severed tissue. U.S. patentapplication Ser. No. 11/267,811, entitled SURGICAL STAPLING INSTRUMENTSSTRUCTURED FOR DELIVERY OF MEDICAL AGENTS, now U.S. Pat. No. 7,673,783,and U.S. patent application Ser. No. 11/267,383, entitled SURGICALSTAPLING INSTRUMENTS STRUCTURED FOR PUMP-ASSISTED DELIVERY OF MEDICALAGENTS, now U.S. Pat. No. 7,607,557, both of which are also incorporatedherein by reference, disclose cutting instruments that use adhesives tofasten the severed tissue. Accordingly, although the description hereinrefers to cutting/stapling operations and the like below, it should berecognized that this is an exemplary embodiment and is not meant to belimiting. Other tissue-fastening techniques may also be used.

FIGS. 4 and 5 are exploded views and FIG. 6 is a side view of the endeffector 12 and shaft 8 according to various embodiments. As shown inthe illustrated embodiment, the shaft 8 may include a proximate closuretube 40 and a distal closure tube 42 pivotably linked by a pivot links44. The distal closure tube 42 includes an opening 45 into which the tab27 on the anvil 24 is inserted in order to open and close the anvil 24,as further described below. Disposed inside the closure tubes 40, 42 maybe a proximate spine tube 46. Disposed inside the proximate spine tube46 may be a main rotational (or proximate) drive shaft 48 thatcommunicates with a secondary (or distal) drive shaft 50 via a bevelgear assembly 52. The secondary drive shaft 50 is connected to a drivegear 54 that engages a proximate drive gear 56 of the helical screwshaft 36. When the main drive shaft 48 is caused to rotate by actuationof the firing trigger 20 (as explained in more detail below), the bevelgear assembly 52 a-c causes the secondary drive shaft 50 to rotate,which in turn, because of the engagement of the drive gears 54, 56,causes the helical screw shaft 36 to rotate, which causes the knife/sleddriving member 32 to travel longitudinally along the channel 22 to cutany tissue clamped within the end effector 12. The vertical bevel gear52 b may sit and pivot in an opening 57 in the distal end of theproximate spine tube 46. A distal spine tube 58 may be used to enclosethe secondary drive shaft 50 and the drive gears 54, 56. Collectively,the main drive shaft 48, the secondary drive shaft 50, and thearticulation assembly (e.g., the bevel gear assembly 52 a-c) aresometimes referred to herein as the “main drive shaft assembly.”

A bearing 38 is threaded on the helical drive screw 36. The bearing 36is also connected to the knife 32. When the helical drive screw 36forward rotates, the bearing 38 traverses the helical drive screw 36distally, driving the cutting instrument 32 and, in the process, thesled 33 to perform the cutting/stapling operation. The sled 33 may bemade of, for example, plastic, and may have a sloped distal surface. Asthe sled 33 traverses the channel 22, the sloped forward surface maypush up or drive the staples in the staple cartridge 34 through theclamped tissue and against the anvil 24. The anvil 24 turns the staples,thereby stapling the severed tissue. When the knife 32 is retracted, theknife 32 and sled 33 may become disengaged, thereby leaving the sled 33at the distal end of the channel 22.

Because of the lack of user feedback for the cutting/stapling operation,there is a general lack of acceptance among physicians of motor-drivensurgical instruments where the cutting/stapling operation is actuated bymerely pressing a button. In contrast, embodiments of the presentinvention provide a motor-driven endocutter with user-feedback of thedeployment, force, and/or position of the cutting instrument in the endeffector.

FIGS. 7-10 illustrate an exemplary embodiment of a motor-drivenendocutter, and in particular the handle 6 thereof, that providesuser-feedback regarding the deployment and loading force of the cuttinginstrument in the end effector. In addition, the embodiment may usepower provided by the user in retracting the firing trigger 20 to powerthe device (a so-called “power assist” mode). As shown in theillustrated embodiment, the handle 6 includes exterior lower side pieces59, 60 and exterior upper side pieces 61, 62 that fit together to form,in general, the exterior of the handle 6. A battery 64, such as a Li ionbattery, may be provided in the pistol grip portion 26 of the handle 6.The battery 64 powers a motor 65 disposed in an upper portion of thepistol grip portion 26 of the handle 6. According to variousembodiments, the motor 65 may be a DC brushed driving motor having amaximum rotation of, approximately, 5000 RPM. The motor 65 may drive a90° bevel gear assembly 66 comprising a first bevel gear 68 and a secondbevel gear 70. The bevel gear assembly 66 may drive a planetary gearassembly 72. The planetary gear assembly 72 may include a pinion gear 74connected to a drive shaft 76. The pinion gear 74 may drive a matingring gear 78 that drives a helical gear drum 80 via a drive shaft 82. Aring 84 may be threaded on the helical gear drum 80. Thus, when themotor 65 rotates, the ring 84 is caused to travel along the helical geardrum 80 by means of the interposed bevel gear assembly 66, planetarygear assembly 72 and ring gear 78.

The handle 6 may also include a run motor sensor 110 in communicationwith the firing trigger 20 to detect when the firing trigger 20 has beendrawn in (or “closed”) toward the pistol grip portion 26 of the handle 6by the operator to thereby actuate the cutting/stapling operation by theend effector 12. The sensor 110 may be a proportional sensor such as,for example, a rheostat or variable resistor. When the firing trigger 20is drawn in, the sensor 110 detects the movement, and sends anelectrical signal indicative of the voltage (or power) to be supplied tothe motor 65. When the sensor 110 is a variable resistor or the like,the rotation of the motor 65 may be generally proportional to the amountof movement of the firing trigger 20. That is, if the operator onlydraws or closes the firing trigger 20 in a little bit, the rotation ofthe motor 65 is relatively low. When the firing trigger 20 is fullydrawn in (or in the fully closed position), the rotation of the motor 65is at its maximum. In other words, the harder the user pulls on thefiring trigger 20, the more voltage is applied to the motor 65, causinggreater rates of rotation.

The handle 6 may include a middle handle piece 104 adjacent to the upperportion of the firing trigger 20. The handle 6 also may comprise a biasspring 112 connected between posts on the middle handle piece 104 andthe firing trigger 20. The bias spring 112 may bias the firing trigger20 to its fully open position. In that way, when the operator releasesthe firing trigger 20, the bias spring 112 will pull the firing trigger20 to its open position, thereby removing actuation of the sensor 110,thereby stopping rotation of the motor 65. Moreover, by virtue of thebias spring 112, any time a user closes the firing trigger 20, the userwill experience resistance to the closing operation, thereby providingthe user with feedback as to the amount of rotation exerted by the motor65. Further, the operator could stop retracting the firing trigger 20 tothereby remove force from the sensor 110, to thereby stop the motor 65.As such, the user may stop the deployment of the end effector 12,thereby providing a measure of control of the cutting/fasteningoperation to the operator.

The distal end of the helical gear drum 80 includes a distal drive shaft120 that drives a ring gear 122, which mates with a pinion gear 124. Thepinion gear 124 is connected to the main drive shaft 48 of the maindrive shaft assembly. In that way, rotation of the motor 65 causes themain drive shaft assembly to rotate, which causes actuation of the endeffector 12, as described above.

The ring 84 threaded on the helical gear drum 80 may include a post 86that is disposed within a slot 88 of a slotted arm 90. The slotted arm90 has an opening 92 at its opposite end 94 that receives a pivot pin 96that is connected between the handle exterior side pieces 59, 60. Thepivot pin 96 is also disposed through an opening 100 in the firingtrigger 20 and an opening 102 in the middle handle piece 104.

In addition, the handle 6 may include a reverse motor (or end-of-strokesensor) 130 and a stop motor (or beginning-of-stroke) sensor 142. Invarious embodiments, the reverse motor sensor 130 may be a limit switchlocated at the distal end of the helical gear drum 80 such that the ring84 threaded on the helical gear drum 80 contacts and trips the reversemotor sensor 130 when the ring 84 reaches the distal end of the helicalgear drum 80. The reverse motor sensor 130, when activated, sends asignal to the motor 65 to reverse its rotation direction, therebywithdrawing the knife 32 of the end effector 12 following the cuttingoperation.

The stop motor sensor 142 may be, for example, a normally-closed limitswitch. In various embodiments, it may be located at the proximate endof the helical gear drum 80 so that the ring 84 trips the switch 142when the ring 84 reaches the proximate end of the helical gear drum 80.

In operation, when an operator of the instrument 10 pulls back thefiring trigger 20, the sensor 110 detects the deployment of the firingtrigger 20 and sends a signal to the motor 65 to cause forward rotationof the motor 65 at, for example, a rate proportional to how hard theoperator pulls back the firing trigger 20. The forward rotation of themotor 65 in turn causes the ring gear 78 at the distal end of theplanetary gear assembly 72 to rotate, thereby causing the helical geardrum 80 to rotate, causing the ring 84 threaded on the helical gear drum80 to travel distally along the helical gear drum 80. The rotation ofthe helical gear drum 80 also drives the main drive shaft assembly asdescribed above, which in turn causes deployment of the knife 32 in theend effector 12. That is, the knife 32 and sled 33 are caused totraverse the channel 22 longitudinally, thereby cutting tissue clampedin the end effector 12. Also, the stapling operation of the end effector12 is caused to happen in embodiments where a stapling-type end effectoris used.

By the time the cutting/stapling operation of the end effector 12 iscomplete, the ring 84 on the helical gear drum 80 will have reached thedistal end of the helical gear drum 80, thereby causing the reversemotor sensor 130 to be tripped, which sends a signal to the motor 65 tocause the motor 65 to reverse its rotation. This in turn causes theknife 32 to retract, and also causes the ring 84 on the helical geardrum 80 to move back to the proximate end of the helical gear drum 80.

The middle handle piece 104 includes a backside shoulder 106 thatengages the slotted arm 90 as best shown in FIGS. 8 and 9. The middlehandle piece 104 also has a forward motion stop 107 that engages thefiring trigger 20. The movement of the slotted arm 90 is controlled, asexplained above, by rotation of the motor 65. When the slotted arm 90rotates CCW as the ring 84 travels from the proximate end of the helicalgear drum 80 to the distal end, the middle handle piece 104 will be freeto rotate CCW. Thus, as the user draws in the firing trigger 20, thefiring trigger 20 will engage the forward motion stop 107 of the middlehandle piece 104, causing the middle handle piece 104 to rotate CCW. Dueto the backside shoulder 106 engaging the slotted arm 90, however, themiddle handle piece 104 will only be able to rotate CCW as far as theslotted arm 90 permits. In that way, if the motor 65 should stoprotating for some reason, the slotted arm 90 will stop rotating, and theuser will not be able to further draw in the firing trigger 20 becausethe middle handle piece 104 will not be free to rotate CCW due to theslotted arm 90.

FIGS. 41 and 42 illustrate two states of a variable sensor that may beused as the run motor sensor 110 according to various embodiments of thepresent invention. The sensor 110 may include a face portion 280, afirst electrode (A) 282, a second electrode (B) 284, and a compressibledielectric material 286 (e.g., EAP) between the electrodes 282, 284. Thesensor 110 may be positioned such that the face portion 280 contacts thefiring trigger 20 when retracted. Accordingly, when the firing trigger20 is retracted, the dielectric material 286 is compressed, as shown inFIG. 42, such that the electrodes 282, 284 are closer together. Sincethe distance “b” between the electrodes 282, 284 is directly related tothe impedance between the electrodes 282, 284, the greater the distancethe more impedance, and the closer the distance the less impedance. Inthat way, the amount that the dielectric material 286 is compressed dueto retraction of the firing trigger 20 (denoted as force “F” in FIG. 42)is proportional to the impedance between the electrodes 282, 284, whichcan be used to proportionally control the motor 65.

Components of an exemplary closure system for closing (or clamping) theanvil 24 of the end effector 12 by retracting the closure trigger 18 arealso shown in FIGS. 7-10. In the illustrated embodiment, the closuresystem includes a yoke 250 connected to the closure trigger 18 by a pin251 that is inserted through aligned openings in both the closuretrigger 18 and the yoke 250. A pivot pin 252, about which the closuretrigger 18 pivots, is inserted through another opening in the closuretrigger 18 which is offset from where the pin 251 is inserted throughthe closure trigger 18. Thus, retraction of the closure trigger 18causes the upper part of the closure trigger 18, to which the yoke 250is attached via the pin 251, to rotate CCW. The distal end of the yoke250 is connected, via a pin 254, to a first closure bracket 256. Thefirst closure bracket 256 connects to a second closure bracket 258.Collectively, the closure brackets 256, 258 define an opening in whichthe proximate end of the proximate closure tube 40 (see FIG. 4) isseated and held such that longitudinal movement of the closure brackets256, 258 causes longitudinal motion by the proximate closure tube 40.The instrument 10 also includes a closure rod 260 disposed inside theproximate closure tube 40. The closure rod 260 may include a window 261into which a post 263 on one of the handle exterior pieces, such asexterior lower side piece 59 in the illustrated embodiment, is disposedto fixedly connect the closure rod 260 to the handle 6. In that way, theproximate closure tube 40 is capable of moving longitudinally relativeto the closure rod 260. The closure rod 260 may also include a distalcollar 267 that fits into a cavity 269 in proximate spine tube 46 and isretained therein by a cap 271 (see FIG. 4).

In operation, when the yoke 250 rotates due to retraction of the closuretrigger 18, the closure brackets 256, 258 cause the proximate closuretube 40 to move distally (i.e., away from the handle end of theinstrument 10), which causes the distal closure tube 42 to movedistally, which causes the anvil 24 to rotate about the pivot point 25into the clamped or closed position. When the closure trigger 18 isunlocked from the locked position, the proximate closure tube 40 iscaused to slide proximally, which causes the distal closure tube 42 toslide proximally, which by virtue of the tab 27 being inserted in thewindow 45 of the distal closure tube 42, causes the anvil 24 to pivotabout the pivot point 25 into the open or unclamped position. In thatway, by retracting and locking the closure trigger 18, an operator mayclamp tissue between the anvil 24 and channel 22, and may unclamp thetissue following the cutting/stapling operation by unlocking the closuretrigger 18 from the locked position.

FIG. 11 is a schematic diagram of an electrical circuit of theinstrument 10 according to various embodiments of the present invention.When an operator initially pulls in the firing trigger 20 after lockingthe closure trigger 18, the sensor 110 is activated, allowing current toflow therethrough. If the normally-open reverse motor sensor switch 130is open (meaning the end of the end effector stroke has not beenreached), current will flow to a single pole, double throw relay 132.Since the reverse motor sensor switch 130 is not closed, the coil 134 ofthe relay 132 will not be energized, so the relay 132 will be in itsnon-energized state. The circuit also includes a cartridge lockoutsensor switch 136. If the end effector 12 includes a staple cartridge34, the sensor switch 136 will be in the closed state, allowing currentto flow. Otherwise, if the end effector 12 does not include a staplecartridge 34, the sensor switch 136 will be open, thereby preventing thebattery 64 from powering the motor 65.

When the staple cartridge 34 is present, the sensor switch 136 isclosed, which energizes a single pole, single throw relay 138. When therelay 138 is energized, current flows through the relay 138, through thevariable resistor sensor 110, and to the motor 65 via a double pole,double throw relay 140, thereby powering the motor 65 and allowing it torotate in the forward direction.

When the end effector 12 reaches the end of its stroke, the reversemotor sensor 130 will be activated, thereby closing the switch 130 andenergizing the relay 132. This causes the relay 132 to assume itsenergized state (not shown in FIG. 11), which causes current to bypassthe cartridge lockout sensor switch 136 and variable resistor 110, andinstead causes current to flow to both the normally-closed double pole,double throw relay 140 and back to the motor 65, but in a manner, viathe relay 140, that causes the motor 65 to reverse its rotationaldirection.

Because the stop motor sensor switch 142 is normally-closed, currentwill flow back to the relay 132 to keep it energized until the switch142 opens. When the knife 32 is fully retracted, the stop motor sensorswitch 142 is activated, causing the switch 142 to open, therebyremoving power from the motor 65.

In other embodiments, rather than a proportional-type sensor 110, anon-off type sensor could be used. In such embodiments, the rate ofrotation of the motor 65 would not be proportional to the force appliedby the operator. Rather, the motor 65 would generally rotate at aconstant rate. But the operator would still experience force feedbackbecause the firing trigger 20 is geared into the gear drive train.

FIG. 12 is a side-view of the handle 6 of a power-assist motorizedendocutter according to another embodiment. The embodiment of FIG. 12 issimilar to that of FIGS. 7-10 except that in the embodiment of FIG. 12,there is no slotted arm 90 connected to the ring 84 threaded on thehelical gear drum 80. Instead, in the embodiment of FIG. 12, the ring 84includes a sensor portion 114 that moves with the ring 84 as the ring 84advances down (and back) on the helical gear drum 80. The sensor portion114 includes a notch 116. The reverse motor sensor 130 may be located atthe distal end of the notch 116 and the stop motor sensor 142 may belocated at the proximate end of the notch 116. As the ring 84 moves downthe helical gear drum 80 (and back), the sensor portion 114 moves withit. Further, as shown in FIG. 12, the middle piece 104 may have an arm118 that extends into the notch 116.

In operation, as an operator of the instrument 10 retracts in the firingtrigger 20 toward the pistol grip 26, the run motor sensor 110 detectsthe motion and sends a signal to power the motor 65, which causes, amongother things, the helical gear drum 80 to rotate. As the helical geardrum 80 rotates, the ring 84 threaded on the helical gear drum 80advances (or retracts, depending on the rotation). Also, due to thepulling in of the firing trigger 20, the middle piece 104 is caused torotate CCW with the firing trigger 20 due to the forward motion stop 107that engages the firing trigger 20. The CCW rotation of the middle piece104 cause the arm 118 to rotate CCW with the sensor portion 114 of thering 84 such that the arm 118 stays disposed in the notch 116. When thering 84 reaches the distal end of the helical gear drum 80, the arm 118will contact and thereby trip the reverse motor sensor 130. Similarly,when the ring 84 reaches the proximate end of the helical gear drum 80,the arm 118 will contact and thereby trip the stop motor sensor 142.Such actions may reverse and stop the motor 65, respectively, asdescribed above.

FIG. 13 is a side-view of the handle 6 of a power-assist motorizedendocutter according to another embodiment. The embodiment of FIG. 13 issimilar to that of FIGS. 7-10 except that in the embodiment of FIG. 13,there is no slot in the arm 90. Instead, the ring 84 threaded on thehelical gear drum 80 includes a vertical channel 126. Instead of a slot,the arm 90 includes a post 128 that is disposed in the channel 126. Asthe helical gear drum 80 rotates, the ring 84 threaded on the helicalgear drum 80 advances (or retracts, depending on the rotation). The arm90 rotates CCW as the ring 84 advances due to the post 128 beingdisposed in the channel 126, as shown in FIG. 13.

As mentioned above, in using a two-stroke motorized instrument, theoperator first pulls back and locks the closure trigger 18. FIGS. 14 and15 show one embodiment of a way to lock the closure trigger 18 to thepistol grip portion 26 of the handle 6. In the illustrated embodiment,the pistol grip portion 26 includes a hook 150 that is biased to rotateCCW about a pivot point 151 by a torsion spring 152. Also, the closuretrigger 18 includes a closure bar 154. As the operator draws in theclosure trigger 18, the closure bar 154 engages a sloped portion 156 ofthe hook 150, thereby rotating the hook 150 upward (or CW in FIGS.14-15) until the closure bar 154 completely passes the sloped portion156 into a recessed notch 158 of the hook 150, which locks the closuretrigger 18 in place. The operator may release the closure trigger 18 bypushing down on a slide button release 160 on the back or opposite sideof the pistol grip portion 26. Pushing down the slide button release 160rotates the hook 150 CW such that the closure bar 154 is released fromthe recessed notch 158.

FIG. 16 shows another closure trigger locking mechanism according tovarious embodiments. In the embodiment of FIG. 16, the closure trigger18 includes a wedge 160 having an arrow-head portion 161. The arrow-headportion 161 is biased downward (or CW) by a leaf spring 162. The wedge160 and leaf spring 162 may be made from, for example, molded plastic.When the closure trigger 18 is retracted, the arrow-head portion 161 isinserted through an opening 164 in the pistol grip portion 26 of thehandle 6. A lower chamfered surface 166 of the arrow-head portion 161engages a lower sidewall 168 of the opening 164, forcing the arrow-headportion 161 to rotate CCW. Eventually the lower chamfered surface 166fully passes the lower sidewall 168, removing the CCW force on thearrow-head portion 161, causing the lower sidewall 168 to slip into alocked position in a notch 170 behind the arrow-head portion 161.

To unlock the closure trigger 18, a user presses down on a button 172 onthe opposite side of the closure trigger 18, causing the arrow-headportion 161 to rotate CCW and allowing the arrow-head portion 161 toslide out of the opening 164.

FIGS. 17-22 show a closure trigger locking mechanism according toanother embodiment. As shown in this embodiment, the closure trigger 18includes a flexible longitudinal arm 176 that includes a lateral pin 178extending therefrom. The arm 176 and pin 178 may be made from moldedplastic, for example. The pistol grip portion 26 of the handle 6includes an opening 180 with a laterally extending wedge 182 disposedtherein. When the closure trigger 18 is retracted, the pin 178 engagesthe wedge 182, and the pin 178 is forced downward (i.e., the arm 176 isrotated CW) by the lower surface 184 of the wedge 182, as shown in FIGS.17 and 18. When the pin 178 fully passes the lower surface 184, the CWforce on the arm 176 is removed, and the pin 178 is rotated CCW suchthat the pin 178 comes to rest in a notch 186 behind the wedge 182, asshown in FIG. 19, thereby locking the closure trigger 18. The pin 178 isfurther held in place in the locked position by a flexible stop 188extending from the wedge 184.

To unlock the closure trigger 18, the operator may further squeeze theclosure trigger 18, causing the pin 178 to engage a sloped backwall 190of the opening 180, forcing the pin 178 upward past the flexible stop188, as shown in FIGS. 20 and 21. The pin 178 is then free to travel outan upper channel 192 in the opening 180 such that the closure trigger 18is no longer locked to the pistol grip portion 26, as shown in FIG. 22.

FIGS. 23A-B show a universal joint (“u joint”) 195. The second piece195-2 of the u-joint 195 rotates in a horizontal plane in which thefirst piece 195-1 lies. FIG. 23A shows the u-joint 195 in a linear(180°) orientation and FIG. 23B shows the u-joint 195 at approximately a150° orientation. The u-joint 195 may be used instead of the bevel gears52 a-c (see FIG. 4, for example) at the articulation point 14 of themain drive shaft assembly to articulate the end effector 12. FIGS. 24A-Bshow a torsion cable 197 that may be used in lieu of both the bevelgears 52 a-c and the u-joint 195 to realize articulation of the endeffector 12.

FIGS. 25-31 illustrate another embodiment of a motorized, two-strokesurgical cutting and fastening instrument 10 with power assist accordingto another embodiment of the present invention. The embodiment of FIGS.25-31 is similar to that of FIGS. 6-10 except that instead of thehelical gear drum 80, the embodiment of FIGS. 25-31 includes analternative gear drive assembly. The embodiment of FIGS. 25-31 includesa gear box assembly 200 including a number of gears disposed in a frame201, wherein the gears are connected between the planetary gear 72 andthe pinion gear 124 at the proximate end of the drive shaft 48. Asexplained further below, the gear box assembly 200 provides feedback tothe user via the firing trigger 20 regarding the deployment and loadingforce of the end effector 12. Also, the user may provide power to thesystem via the gear box assembly 200 to assist the deployment of the endeffector 12. In that sense, like the embodiments described above, theembodiment of FIGS. 25-31 is another power assist, motorized instrument10 that provides feedback to the user regarding the loading forceexperienced by the cutting instrument 32.

In the illustrated embodiment, the firing trigger 20 includes twopieces: a main body portion 202 and a stiffening portion 204. The mainbody portion 202 may be made of plastic, for example, and the stiffeningportion 204 may be made out of a more rigid material, such as metal. Inthe illustrated embodiment, the stiffening portion 204 is adjacent tothe main body portion 202, but according to other embodiments, thestiffening portion 204 could be disposed inside the main body portion202. A pivot pin 207 may be inserted through openings in the firingtrigger pieces 202, 204 and may be the point about which the firingtrigger 20 rotates. In addition, a spring 222 may bias the firingtrigger 20 to rotate in a CCW direction. The spring 222 may have adistal end connected to a pin 224 that is connected to the pieces 202,204 of the firing trigger 20. The proximate end of the spring 222 may beconnected to one of the handle exterior lower side pieces 59, 60.

In the illustrated embodiment, both the main body portion 202 and thestiffening portion 204 include gear portions 206, 208 (respectively) attheir upper end portions. The gear portions 206, 208 engage a gear inthe gear box assembly 200, as explained below, to drive the main driveshaft assembly and to provide feedback to the user regarding thedeployment of the end effector 12.

The gear box assembly 200 may include as shown, in the illustratedembodiment, six (6) gears. A first gear 210 of the gear box assembly 200engages the gear portions 206, 208 of the firing trigger 20. Inaddition, the first gear 210 engages a smaller second gear 212, thesmaller second gear 212 being coaxial with a large third gear 214. Thethird gear 214 engages a smaller fourth gear 216, the smaller fourthgear 216 being coaxial with a fifth gear 218. The fifth gear 218 is a90° bevel gear that engages a mating 90° bevel gear 220 (best shown inFIG. 31) that is connected to the pinion gear 124 that drives the maindrive shaft 48.

In operation, when the user retracts the firing trigger 20, a run motorsensor (not shown) is activated, which may provide a signal to the motor65 to rotate at a rate proportional to the extent or force with whichthe operator is retracting the firing trigger 20. This causes the motor65 to rotate at a speed proportional to the signal from the sensor. Thesensor is not shown for this embodiment, but it could be similar to therun motor sensor 110 described above. The sensor could be located in thehandle 6 such that it is depressed when the firing trigger 20 isretracted. Also, instead of a proportional-type sensor, an on/off typesensor may be used.

Rotation of the motor 65 causes the bevel gears 66, 70 to rotate, whichcauses the planetary gear 72 to rotate, which causes, via the driveshaft 76, the ring gear 122 to rotate. The ring gear 122 meshes with thepinion gear 124, which is connected to the main drive shaft 48. Thus,rotation of the pinion gear 124 drives the main drive shaft 48, whichcauses actuation of the cutting/stapling operation of the end effector12.

Forward rotation of the pinion gear 124 in turn causes the bevel gear220 to rotate, which causes, by way of the rest of the gears of the gearbox assembly 200, the first gear 210 to rotate. The first gear 210engages the gear portions 206, 208 of the firing trigger 20, therebycausing the firing trigger 20 to rotate CCW when the motor 65 providesforward drive for the end effector 12 (and to rotate CCW when the motor65 rotates in reverse to retract the end effector 12). In that way, theuser experiences feedback regarding loading force and deployment of theend effector 12 by way of the user's grip on the firing trigger 20.Thus, when the user retracts the firing trigger 20, the operator willexperience a resistance related to the load force experienced by the endeffector 12. Similarly, when the operator releases the firing trigger 20after the cutting/stapling operation so that it can return to itsoriginal position, the user will experience a CW rotation force from thefiring trigger 20 that is generally proportional to the reverse speed ofthe motor 65.

It should also be noted that in this embodiment the user can apply force(either in lieu of or in addition to the force from the motor 65) toactuate the main drive shaft assembly (and hence the cutting/staplingoperation of the end effector 12) through retracting the firing trigger20. That is, retracting the firing trigger 20 causes the gear portions206, 208 to rotate CCW, which causes the gears of the gear box assembly200 to rotate, thereby causing the pinion gear 124 to rotate, whichcauses the main drive shaft 48 to rotate.

Although not shown in FIGS. 25-31, the instrument 10 may further includereverse motor and stop motor sensors. As described above, the reversemotor and stop motor sensors may detect, respectively, the end of thecutting stroke (full deployment of the knife 32 and sled 33) and the endof retraction operation (full retraction of the knife 32). A circuitsimilar to that described above in connection with FIG. 11 may be usedto appropriately power the motor 65.

FIGS. 32-36 illustrate a two-stroke, motorized surgical cutting andfastening instrument 10 with power assist according to anotherembodiment. The embodiment of FIGS. 32-36 is similar to that of FIGS.25-31 except that in the embodiment of FIGS. 32-36, the firing trigger20 includes a lower portion 228 and an upper portion 230. Both portions228, 230 are connected to and pivot about a pivot pin 207 that isdisposed through each portion 228, 230. The upper portion 230 includes agear portion 232 that engages the first gear 210 of the gear boxassembly 200. The spring 222 is connected to the upper portion 230 suchthat the upper portion is biased to rotate in the CW direction. Theupper portion 230 may also include a lower arm 234 that contacts anupper surface of the lower portion 228 of the firing trigger 20 suchthat when the upper portion 230 is caused to rotate CW the lower portion228 also rotates CW, and when the lower portion 228 rotates CCW theupper portion 230 also rotates CCW. Similarly, the lower portion 228includes a rotational stop 238 that engages a lower shoulder of theupper portion 230. In that way, when the upper portion 230 is caused torotate CCW the lower portion 228 also rotates CCW, and when the lowerportion 228 rotates CW the upper portion 230 also rotates CW.

The illustrated embodiment also includes the run motor sensor 110 thatcommunicates a signal to the motor 65 that, in various embodiments, maycause the motor 65 to rotate at a speed proportional to the forceapplied by the operator when retracting the firing trigger 20. Thesensor 110 may be, for example, a rheostat or some other variableresistance sensor, as explained herein. In addition, the instrument 10may include a reverse motor sensor 130 that is tripped or switched whencontacted by a front face 242 of the upper portion 230 of the firingtrigger 20. When activated, the reverse motor sensor 130 sends a signalto the motor 65 to reverse direction. Also, the instrument 10 mayinclude a stop motor sensor 142 that is tripped or actuated whencontacted by the lower portion 228 of the firing trigger 20. Whenactivated, the stop motor sensor 142 sends a signal to stop the reverserotation of the motor 65.

In operation, when an operator retracts the closure trigger 18 into thelocked position, the firing trigger 20 is retracted slightly (throughmechanisms known in the art, including U.S. Pat. No. 6,978,921, entitledSURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISMand U.S. Pat. No. 6,905,057, entitled SURGICAL STAPLING INSTRUMENTINCORPORATING A FIRING MECHANISM HAVING A LINKED RACK TRANSMISSION, bothof which are incorporated herein by reference) so that the user cangrasp the firing trigger 20 to initiate the cutting/stapling operation,as shown in FIGS. 32 and 33. At that point, as shown in FIG. 33, thegear portion 232 of the upper portion 230 of the firing trigger 20 movesinto engagement with the first gear 210 of the gear box assembly 200.When the operator retracts the firing trigger 20, according to variousembodiments, the firing trigger 20 may rotate a small amount, such asfive degrees, before tripping the run motor sensor 110, as shown in FIG.34. Activation of the sensor 110 causes the motor 65 to forward rotateat a rate proportional to the retraction force applied by the operator.The forward rotation of the motor 65 causes, as described above, themain drive shaft 48 to rotate, which causes the knife 32 in the endeffector 12 to be deployed (i.e., begin traversing the channel 22).Rotation of the pinion gear 124, which is connected to the main driveshaft 48, causes the gears 210-220 in the gear box assembly 200 torotate. Since the first gear 210 is in engagement with the gear portion232 of the upper portion 230 of the firing trigger 20, the upper portion230 is caused to rotate CCW, which causes the lower portion 228 to alsorotate CCW.

When the knife 32 is fully deployed (i.e., at the end of the cuttingstroke), the front face 242 of the upper portion 230 trips the reversemotor sensor 130, which sends a signal to the motor 65 to reverserotational direction. This causes the main drive shaft assembly toreverse rotational direction to retract the knife 32. Reverse rotationof the main drive shaft assembly causes the gears 210-220 in the gearbox assembly to reverse direction, which causes the upper portion 230 ofthe firing trigger 20 to rotate CW, which causes the lower portion 228of the firing trigger 20 to rotate CW until the front face 242 of theupper portion 230 trips or actuates the stop motor sensor 142 when theknife 32 is fully retracted, which causes the motor 65 to stop. In thatway, the user experiences feedback regarding deployment of the endeffector 12 by way of the user's grip on the firing trigger 20. Thus,when the user retracts the firing trigger 20, the operator willexperience a resistance related to the deployment of the end effector 12and, in particular, to the loading force experienced by the knife 32.Similarly, when the operator releases the firing trigger 20 after thecutting/stapling operation so that it can return to its originalposition, the user will experience a CW rotation force from the firingtrigger 20 that is generally proportional to the reverse speed of themotor 65.

It should also be noted that in this embodiment the user can apply force(either in lieu of or in addition to the force from the motor 65) toactuate the main drive shaft assembly (and hence the cutting/staplingoperation of the end effector 12) through retracting the firing trigger20. That is, retracting the firing trigger 20 causes the gear portion232 of the upper portion 230 to rotate CCW, which causes the gears ofthe gear box assembly 200 to rotate, thereby causing the pinion gear 124to rotate, which causes the main drive shaft assembly to rotate.

The above-described embodiments employed power-assist user feedbacksystems, with or without adaptive control (e.g., using a sensor 110,130, and 142 outside of the closed loop system of the motor, gear drivetrain, and end effector) for a two-stroke, motorized surgical cuttingand fastening instrument. That is, force applied by the user inretracting the firing trigger 20 may be added to the force applied bythe motor 65 by virtue of the firing trigger 20 being geared into(either directly or indirectly) the gear drive train between the motor65 and the main drive shaft 48. In other embodiments of the presentinvention, the user may be provided with tactile feedback regarding theposition of the knife 32 in the end effector 12, but without having thefiring trigger 20 geared into the gear drive train. FIGS. 37-40illustrate a motorized surgical cutting and fastening instrument 10 withsuch a tactile position feedback system.

In the illustrated embodiment of FIGS. 37-40, the firing trigger 20 mayhave a lower portion 228 and an upper portion 230, similar to theinstrument 10 shown in FIGS. 32-36. Unlike the embodiment of FIGS.32-36, however, the upper portion 230 does not have a gear portion thatmates with part of the gear drive train. Instead, the instrument 10includes a second motor 265 with a threaded rod 266 threaded therein.The threaded rod 266 reciprocates longitudinally in and out of the motor265 as the motor 265 rotates, depending on the direction of rotation.The instrument 10 also includes an encoder 268 that is responsive to therotations of the main drive shaft 48 for translating the incrementalangular motion of the main drive shaft 48 (or other component of themain drive assembly) into a corresponding series of digital signals, forexample. In the illustrated embodiment, the pinion gear 124 includes aproximate drive shaft 270 that connects to the encoder 268.

The instrument 10 also includes a control circuit (not shown), which maybe implemented using a microcontroller or some other type of integratedcircuit, that receives the digital signals from the encoder 268. Basedon the signals from the encoder 268, the control circuit may calculatethe stage of deployment of the knife 32 in the end effector 12. That is,the control circuit can calculate if the knife 32 is fully deployed,fully retracted, or at an intermittent stage. Based on the calculationof the stage of deployment of the end effector 12, the control circuitmay send a signal to the second motor 265 to control its rotation tothereby control the reciprocating movement of the threaded rod 266.

In operation, as shown in FIG. 37, when the closure trigger 18 is notlocked into the clamped position, the firing trigger 20 rotated awayfrom the pistol grip portion 26 of the handle 6 such that the front face242 of the upper portion 230 of the firing trigger 20 is not in contactwith the proximate end of the threaded rod 266. When the operatorretracts the closure trigger 18 and locks it in the clamped position,the firing trigger 20 rotates slightly towards the closure trigger 18 sothat the operator can grasp the firing trigger 20, as shown in FIG. 38.In this position, the front face 242 of the upper portion 230 contactsthe proximate end of the threaded rod 266.

As the user then retracts the firing trigger 20, after an initialrotational amount (e.g., 5 degrees of rotation) the run motor sensor 110may be activated such that, as explained above, the sensor 110 sends asignal to the motor 65 to cause it to rotate at a forward speedproportional to the amount of retraction force applied by the operatorto the firing trigger 20. Forward rotation of the motor 65 causes themain drive shaft 48 to rotate via the gear drive train, which causes theknife 32 and sled 33 to travel down the channel 22 and sever tissueclamped in the end effector 12. The control circuit receives the outputsignals from the encoder 268 regarding the incremental rotations of themain drive shaft assembly and sends a signal to the second motor 265 tocause the second motor 265 to rotate, which causes the threaded rod 266to retract into the motor 265. This allows the upper portion 230 of thefiring trigger 20 to rotate CCW, which allows the lower portion 228 ofthe firing trigger to also rotate CCW. In that way, because thereciprocating movement of the threaded rod 266 is related to therotations of the main drive shaft assembly, the operator of theinstrument 10, by way of his/her grip on the firing trigger 20,experiences tactile feedback as to the position of the end effector 12.The retraction force applied by the operator, however, does not directlyaffect the drive of the main drive shaft assembly because the firingtrigger 20 is not geared into the gear drive train in this embodiment.

By virtue of tracking the incremental rotations of the main drive shaftassembly via the output signals from the encoder 268, the controlcircuit can calculate when the knife 32 is fully deployed (i.e., fullyextended). At this point, the control circuit may send a signal to themotor 65 to reverse direction to cause retraction of the knife 32. Thereverse direction of the motor 65 causes the rotation of the main driveshaft assembly to reverse direction, which is also detected by theencoder 268. Based on the reverse rotation detected by the encoder 268,the control circuit sends a signal to the second motor 265 to cause itto reverse rotational direction such that the threaded rod 266 starts toextend longitudinally from the motor 265. This motion forces the upperportion 230 of the firing trigger 20 to rotate CW, which causes thelower portion 228 to rotate CW. In that way, the operator may experiencea CW force from the firing trigger 20, which provides feedback to theoperator as to the retraction position of the knife 32 in the endeffector 12. The control circuit can determine when the knife 32 isfully retracted. At this point, the control circuit may send a signal tothe motor 65 to stop rotation.

According to other embodiments, rather than having the control circuitdetermine the position of the knife 32, reverse motor and stop motorsensors may be used, as described above. In addition, rather than usinga proportional sensor 110 to control the rotation of the motor 65, anon/off switch or sensor can be used. In such an embodiment, the operatorwould not be able to control the rate of rotation of the motor 65.Rather, it would rotate at a preprogrammed rate.

FIG. 43 illustrates various embodiments of a surgical instrument 300.The surgical instrument 300 may be similar to the surgical instrument 10described hereinabove, but also includes a status module 302 releasablyconnected thereto. Although the status module 302 is shown in FIG. 43 asbeing connected to the exterior lower side piece 60 of the handle 6, itis understood that the status module 302 may be connected to thesurgical instrument 300 at any suitable location. According to variousembodiments, the handle 6 of the surgical instrument 300 defines arecess structured and arranged to receive the status module 302.

The surgical instrument 300 comprises a plurality of sensors 304 (shownschematically in FIG. 44), wherein the plurality of sensors 304includes, for example, an articulation angle sensor, an anvil positionsensor, a cartridge sensor, a closure trigger sensor, a closure forcesensor, a firing force sensor, a knife position sensor, a lockoutcondition sensor, or any combination thereof. Each sensor 304 may be inelectrical communication with a different contact 306 (shownschematically in FIG. 44) positioned proximate the exterior of thesurgical instrument 300.

The sensors 304 may be embodied in any suitable manner. For example, thearticulation angle sensor may be embodied as, for example, apotentiometer that comprises a portion of the articulation control 16and outputs a signal that indicates the relative articulation angle ofthe end effector 12. The anvil position sensor may be embodied as, forexample, the anvil closure sensor 2004 disclosed in U.S. Pat. No.7,845,537, entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES.The cartridge sensor may be embodied as, for example, the cartridgepresent sensor 2010 disclosed in U.S. Pat. No. 7,845,537, entitledSURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES. The closure triggersensor may be embodied as, for example, the closure trigger sensor 2002disclosed in U.S. Pat. No. 7,845,537, entitled SURGICAL INSTRUMENTHAVING RECORDING CAPABILITIES. The closure force sensor may be embodiedas, for example, the anvil closure load sensor 2006 disclosed in U.S.Pat. No. 7,845,537, entitled SURGICAL INSTRUMENT HAVING RECORDINGCAPABILITIES. The firing force sensor may be embodied as, for example,the firing trigger sensor 110 disclosed in U.S. Pat. No. 7,845,537,entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES. The knifeposition sensor may be embodied as, for example, the knife positionsensor 2008 disclosed in U.S. Pat. No. 7,845,537, entitled SURGICALINSTRUMENT HAVING RECORDING CAPABILITIES. The lockout condition sensormay be embodied as, for example, the cartridge lockout sensor 136 or thecartridge present sensor 2010 disclosed in U.S. Pat. No. 7,845,537,entitled SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES.

According to various embodiments, the status module 302 comprises ahousing 308 structured and arranged to releasably connect to thesurgical instrument 300. The status module 308 comprises a plurality ofcontacts 310 (shown schematically in FIG. 44), wherein each individualcontact 310 is structured and arranged to be in electrical communicationwith a different sensor 304 of the surgical instrument 300 when thehousing 308 is connected to the surgical instrument 300. For example,when the status module 302 is connected to the surgical instrument 300,each contact 310 of the status module 302 may be aligned with arespective corresponding contact 306 of the surgical instrument 300,thereby placing each contact 310 of the status module 302 in electricalcommunication with a different sensor 304.

The status module 302 further comprises a circuit 312 (shownschematically in FIG. 44) in communication with at least one of thecontacts 310, and a plurality of indicators 314 (shown schematically inFIG. 44). At least one of the indicators 314 is in electricalcommunication with the circuit 312. The circuit 312 comprises a drivecircuit, and is structured and arranged to drive at least one of theindicators 314. According to various embodiments, the circuit 312 mayfurther comprise, as shown schematically in FIG. 44, a switch 316, acounter 318, a transmitter 320, or any combination thereof.

The switch 316 is in electrical communication with at least one of theindicators 314, and may be utilized to disable the respective indicator314 that is in electrical communication therewith. According to variousembodiments, the switch 316 may comprise a portion of the status module302 other than the circuit 312, or a portion of the surgical instrument300 other than the status module 302. For such embodiments, the switch316 may be in electrical communication with the circuit 312.

The counter 318 may be utilized to determine the number of firings, thenumber of firings remaining, the post-clamping wait time, etc. Accordingto various embodiments, the counter 318 may comprise a portion of thestatus module 302 other than the circuit 312. According to otherembodiments, the counter 318 may comprise a portion of the surgicalinstrument 300 other than the status module 302. For such embodiments,the counter 318 may be in electrical communication with the circuit 312.

The transmitter 320 may be utilized to wirelessly transmit informationsensed by the plurality of sensors 304 to a wireless receiver (notshown) associated with a monitor (not shown) that may be viewed by auser of the surgical instrument 300 while the user is performing aprocedure. The information may be wirelessly transmitted continuously orperiodically. The displayed information may include, for example, firingprogress information, compression load information, knife loadinformation, number of firings, procedure time, compression wait time,battery level, etc. According to other various embodiments, thetransmitter 320 may comprise a portion of the status module 302 otherthan the circuit 312, or a portion of the surgical instrument 300 otherthan the status module 302. For such embodiments, the transmitter 320may be in electrical communication with the circuit 312.

FIGS. 45-47 illustrate various embodiments of the status module 302. Asshown, the status module 302 may comprise different types of indicators314. According to various embodiments, the indicators 314 may compriseone or more visual indicators such as, for example, a light emittingdiode, a multi-color light emitting diode, a display, etc. or anycombination thereof. The display may comprise, for example, an alphanumeric display, a dot matrix display, a liquid crystal display, etc.According to various embodiments, at least one of the indicators 314 maycomprise an audible indicator such as, for example, an audio outputdevice. The audible output device may be embodied as, for example, aspeaker, and may be in electrical communication with the switch 316.According to various embodiments, the indicators 314 may comprise atleast one visual indicator and at least one audible indicator.

In operation, the indicators 314 may provide visual and audible feedbackto a user of the surgical instrument 300. For example, as shown in FIG.45, an indicator 314 (e.g., a light emitting diode) may be utilized toindicate whether the closure trigger 18 is in the locked position,whether a predetermined post-clamping wait period has been completed,whether a staple cartridge 34 is loaded, etc. Different indicators 314may emit different colors of light. As used in FIGS. 45 and 46,different hatching indicates different colors. An indicator 314 (e.g., amulti-color light emitting diode) may be utilized for multiple statusindications of a particular function of the surgical instrument 300. Forexample, to indicate the status of the staple cartridge 34, amulti-color light emitting diode may emit green light if a loaded staplecartridge 34 is in the channel 22, yellow light if a spent staplecartridge 34 is in the channel 22, or red light if a staple cartridge 34is not in the channel 22. Similarly, to indicate the status of a cuttingforce being exerted by the surgical instrument 300, a multi-color lightemitting diode may emit green light if the cutting force being exertedis in a normal range, yellow light if the cutting force being exerted isin an elevated range, or red light if the cutting force being exerted isin a high load range. It is understood that the indicators 314 may beutilized for multiple status indications of other functions of thesurgical instrument 300 such as, for example, battery level.

As shown in FIG. 45, a line of indicators 314 (e.g., light emittingdiodes) may be utilized to indicate the progression of the knife 32, thepercentage of the maximum closure force being exerted, the percentage ofthe maximum firing force being exerted, the current articulation angleof the end effector 12, etc. Such indications may provide a user of thesurgical instrument 300 with feedback concerning the forces involved inoperating the surgical instrument 300 and feedback as to how close thesurgical instrument 300 is operating to its maximum capacity. Althoughonly one line of indicators 314 is shown in FIG. 45, it is understoodthat the status module 302 may comprise any number of lines ofindicators 314.

As shown in FIG. 46, the status module 302 may comprise indicators 314(e.g., light emitting diodes) arranged in two circular orientations. Forsuch embodiments, the status module 302 may be capable of providing moreconcurrent information to a user of the surgical instrument 300 than thestatus module 302 shown in FIG. 45. Although two circular arrangementsof indicators are shown in FIG. 46, it is understood that the statusmodule 302 may comprise any number of indicators 314 arranged in anynumber of orientations. For example, the status module 302 may comprisesindicators 314 arranged in a pyramid pattern.

As shown in FIG. 47, the indicators 314 of the status module 302 maycomprise a line of light emitting diodes and at least one display (e.g.,a liquid crystal display). For such embodiments, the status module 302may be capable of providing more concurrent information to a user of thesurgical instrument 300 than the status module 302 shown in FIG. 45 orFIG. 46. For example, the light emitting diodes may show reaction forceat the anvil 24 and staple cartridge 22, the battery level, thearticulation angle, etc. in the form of a bar graph. The display mayshow information concerning closure forces, firing forces, the number offirings remaining, post-clamping wait time, stroke progression,articulation angle, etc. in the form of digits.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A status module for use with a surgicalinstrument comprising a plurality of sensors, the status modulecomprising: a housing structured and arranged to releasably connect tothe surgical instrument; a plurality of contacts, wherein eachindividual contact is structured and arranged to be in electricalcommunication with a different sensor when the housing is connected tothe surgical instrument; a circuit in electrical communication with atleast one of the contacts; and a plurality of indicators, wherein atleast one of the indicators is in electrical communication with thecircuit.
 2. The status module of claim 1, wherein the circuit comprisesa drive circuit.
 3. The status module of claim 2, wherein the circuitfurther comprises a counter.
 4. The status module of claim 1, whereinthe plurality of indicators comprises a visual indicator in electricalcommunication with the circuit.
 5. The status module of claim 4, whereinthe visual indicator comprises a light emitting diode.
 6. The statusmodule of claim 4, wherein the visual indicator comprises at least oneof the following: an alpha numeric display; a dot matrix display; and aliquid crystal display.
 7. The status module of claim 1, wherein theplurality of indicators comprises: a visual indicator in electricalcommunication with the circuit; and an audible indicator in electricalcommunication with the circuit.
 8. The status module of claim 7, whereinthe audible indicator comprises an audio output device.
 9. The statusmodule of claim 7, further comprising a switch in electricalcommunication with the audible indicator.
 10. The status module of claim1, further comprising a transmitter in electrical communication with thecircuit.
 11. A surgical instrument, comprising: a plurality of sensors;and a status module releasably connected to the surgical instrument,wherein the status module comprises: a plurality of contacts, whereineach individual contact is in electrical communication with a differentsensor; a circuit in electrical communication with at least one of thecontacts; and a plurality of indicators, wherein at least one of theindicators is in electrical communication with the circuit.
 12. Thesurgical instrument of claim 11, wherein the plurality of sensorscomprises at least one of the following: an articulation angle sensor;an anvil position sensor; a cartridge sensor; a closure trigger sensor;a closure force sensor; a firing force sensor; a knife position sensor;and a lockout condition sensor.
 13. The surgical instrument of claim 11,wherein the circuit comprises a drive circuit.
 14. The surgicalinstrument of claim 11, wherein the plurality of indicators comprises avisual indicator in electrical communication with the circuit.
 15. Thesurgical instrument of claim 14, wherein the visual indicator comprisesa light emitting diode.
 16. The surgical instrument of claim 14, whereinthe visual indicator comprises one of the following: an alpha numericdisplay; a dot matrix display; and a liquid crystal display.
 17. Thesurgical instrument of claim 11, wherein the plurality of indicatorscomprises: a visual indicator in electrical communication with thecircuit; and an audible indicator in electrical communication with thecircuit.
 18. The surgical instrument of claim 17, wherein the audibleindicator is an audio output device.
 19. The surgical instrument ofclaim 17, further comprising a switch in electrical communication withthe audible indicator.
 20. The surgical instrument of claim 11, furthercomprising a transmitter in electrical communication with the circuit.